IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- The presence/absence of an activation profile
研究概览
简要总结
The primary objective of this study is to search for, in vitro, elements associated with IgG-dependent monocyte activation (signaling pathway activation, expression of pro-coagulant and pro-inflammatory factors) and to describe their prevalence in female patients with a history of proximal venous thromboembolism (proximal deep vein thrombosis or pulmonary embolism) compared to control women.
详细描述
The secondary objectives of this study include to compare the IgG-dependent monocyte activation profiles as a function of laboratory thrombophilia parameters. Essentially: Is IgG-dependent cell activation associated with the presence of anti-phospholipid antibodies (or their subtypes?), or do these profiles indicate something beyond the nosology of anti-phospholipid syndrome?
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The presence/absence of an activation profile
时间窗: Day (0)
The following will be taken into account: Six signaling pathways (Protein kinase B, extracellular-signal-regulated kinases, Signal transducer and activator of transcription 5, P38 mitogen-activated protein kinases, Mechanistic Target Of Rapamycin, nuclear factor kappa-light-chain-enhancer of activated B cells), increases in the expression of tissue factor, and 5 pro-inflammatory factors (Intercellular Adhesion Molecule, tumor necrosis factor alpha, interferon gamma, Interleukin-1 beta, Interleukin 8). A pathway will be considered as "activated" or an expression profile as "increased" when the observed value is superior to the 95% confidence interval determined using healthy volunteer values. A patient is considered as having an activation profile if at least one of the above pathways or expressions is considered as activated / increased.
次要结局
- The presence / absence of a constitutional biological thrombophilia(Day (0))
- Fibrin monomer (blood; mg/ L)(Day (0))
- History of proximal deep vein thrombosis? yes/no(Day (0))
- History of placental vascular pathology? yes/no(Day (0))
- The presence / absence of antiphospholipid antibodies: lupus anticoagulant antibodies(Day (0))
- Blood D-dimers (ng/mL)(Day (0))
- History of pulmonary embolism? yes/no(Day (0))
- The presence / absence of antiphospholipid antibodies: anti-beta2-glycoprotein 1 antibodies(Day (0))
- The presence / absence of antiphospholipid antibodies: anti-cardiolipid antibodies(Day (0))